BETA-CATH XL DELIVERY CATHETER - 60 MM
FDA premarket approval P000018/S021 · decided 2002-10-25
Approval details
- PMA number
- P000018
- Supplement
- S021
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BETA-CATH XL DELIVERY CATHETER - 60 MM
- Generic name
- Intravascular radiation delivery system
- Applicant
- Best Vascular, Inc.
- Date received
- 2002-05-01
- Decision date
- 2002-10-25
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- MOU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Norcross, GA
- Statement
- APPROVAL FOR THE 60 MM BETA-CATH XL DELIVERY CATHETER.
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